Extracorporeal blood treatment machine, computer-implemented control method for the same, and computer program
The dialysis machine adjusts the oxygen content in the fresh dialysis fluid through a continuously adjustable throttle device, addressing hypoxemia issues in existing machines by maintaining optimal oxygen levels in the blood, thereby enhancing treatment efficiency and safety.
Patent Information
- Application Number
- EP2025153435
- Authority / Receiving Office
- EP · EP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2024-01-29
- Filing Date
- 2025-01-22
- Publication Date
- 2025-07-30
AI Technical Summary
Existing extracorporeal blood treatment machines, such as dialysis machines, cause hypoxemia due to complete degassing of ultrapure water, leading to increased oxygen excretion from the blood and reduced oxygen content in the venous blood, which is inefficient and potentially harmful.
A dialysis machine with a continuously adjustable throttle device controls the degassing pressure of ultrapure water to adjust the oxygen content in the fresh dialysis fluid, allowing for precise regulation of oxygen levels in the blood via the semipermeable membrane, using a sensor unit to monitor blood components and a control unit to manage the throttle device.
This approach enables safer and more efficient extracorporeal blood treatment by maintaining optimal oxygen levels in the blood, reducing hypoxemia and enhancing therapy effectiveness.
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Abstract
Description
Technical area
[0001] The present disclosure relates to an extracorporeal blood treatment machine, in particular a dialysis machine, for extracorporeal blood treatment such as hemodialysis, hemofiltration, hemodiafiltration, and / or ultrafiltration. The blood treatment machine comprises a dialyzer with a semipermeable membrane for mass transfer between a patient's blood and a dialysis fluid, an extracorporeal blood circuit that runs through the dialyzer via a blood inlet and a blood outlet of the dialyzer, a sensor unit for detecting a blood component in the blood that correlates with an oxygen content in the blood, a degassing unit with a throttle device, via which ultrapure water provided in a gaseous state can be throttled to a degassing pressure in order to provide the at least partially degassed ultrapure water at an outlet of the degassing unit, and a pressure detection unit.via which the degassing pressure is detected, a mixing unit in which the at least partially degassed ultrapure water is mixed with at least one concentrate to form a fresh dialysis fluid and is provided to a dialysis fluid circuit of the blood treatment machine, and a control unit that is signal-connected to the sensor unit, the pressure detection unit, and the throttle device. In addition, the present disclosure relates to a computer-implemented control method for an extracorporeal blood treatment machine and a computer program according to the preambles of the independent claims. Technical background
[0002] In extracorporeal blood treatment, for example blood purification in the form of hemodialysis, hemofiltration or hemodiafiltration, blood is taken from a dialysis patient via an arterial vascular access and fed to a dialyzer for blood treatment via an extracorporeal blood circuit. Fresh dialysis fluid, prepared as needed, is also fed to the dialyzer via a dialysis fluid circuit. To produce the fresh dialysis fluid, ultrapure water is provided by a water treatment plant, in particular a reverse osmosis system, degassed and then mixed with at least one concentrate in a mixing unit. Conventional blood treatment / dialysis machines currently degas completely, in particular to ensure precise ultrafiltration. Degassing occurs when the ultrapure water flows through a fixed throttle, thereby experiencing a pressure loss.The pressure is released and then passed through a degassing chamber with a large surface area. The surface allows for the efficient separation of the gas components of the ultrapure water released due to the pressure loss. The degassed ultrapure water then enters the aforementioned mixing unit for the production of the dialysis fluid.
[0003] In the dialyzer, the blood from the extracorporeal blood circuit and the dialysis fluid from the dialysis fluid circuit are brought into contact via the semipermeable membrane, allowing a substance exchange between the blood and the dialysis fluid. This allows harmful substances to be removed from the blood during dialysis treatment of patients with renal insufficiency, as well as excess water that accumulates in the body due to underlying kidney failure. The purified blood is then returned to the patient via a venous access.
[0004] It should be noted that the exchange of substances between the blood in the extracorporeal circulation and the dialysis fluid can occur in both directions. The resulting direction of substance transport depends on the concentration of the respective component in the blood / dialysis fluid. The oxygen content of the dialysis fluid is important for hemodialysis, as oxygen is highly permeable and, depending on the gradient, substance transport can be expected with a sufficient partial pressure difference between the blood in the extracorporeal circulation and the fresh dialysis fluid.
[0005] Since the partial pressure of oxygen in the fresh dialysis fluid approaches zero due to the complete degassing of the state-of-the-art blood treatment machine, and the fresh dialysis fluid is brought into contact with the oxygenated blood of the extracorporeal blood circuit at the dialyzer's semipermeable membrane, increased excretion of oxygen dissolved in the blood of the extracorporeal blood circuit and, consequently, hypoxemia of the venous blood in the extracorporeal blood circuit can be expected according to the current state of the art. This adverse effect can be avoided or at least reduced if it is possible to influence the partial pressure in the blood of the extracorporeal blood circuit.
[0006] Methods for influencing a gas component in an extracorporeal blood circuit are fundamentally known from the prior art. For example, membrane oxygenation combines continuous renal replacement therapy (CRRT) with venovenous, extracorporeal removal of carbon dioxide CO 2 (ECCO 2 R). In this case, a peristaltic pump pumps blood from an arterial tube section of the extracorporeal blood circuit at a flow rate of approximately 10 ml / min to 500 ml / min into a CO 2 absorber (ECCO 2 R filter). The CO 2 absorber has an oxygen pressure connection fed by an external oxygen container. The oxygen flushing gas flow thus provided removes the CO 2 from the blood in the arterial tube section.
[0007] The disadvantage of this solution is that the necessary CO2 absorber, the oxygen tank and the piping system for the supply and removal of the rinsing oxygen represent a comparatively high equipment complexity, which is reflected in costs and high space requirements. Summary of the present disclosure
[0008] The object of the present disclosure is, in contrast, to avoid or at least mitigate the disadvantages of the prior art and, in particular, to provide an extracorporeal blood treatment machine, as well as a computer-implemented control method and computer program, which provides an even more efficient and safer therapy of an extracorporeal blood treatment.
[0009] The object of the present disclosure is achieved with regard to an extracorporeal blood treatment machine by the features of claim 1, with regard to a computer-implemented control method by the features of claim 10, and with regard to a computer program by the features of claim 15.
[0010] A basic concept of the present disclosure provides that a blood treatment machine is adapted to influence the oxygen content in the blood during blood treatment by influencing the oxygen content in the fresh dialysis fluid. For this purpose, the degassing pressure of gas-containing ultrapure water, which is provided for the preparation of the fresh dialysis fluid, is specifically adjusted or set by means of a continuously adjustable throttle device.
[0011] In other words, an extracorporeal blood treatment machine, in particular a dialysis machine, is provided for extracorporeal blood treatment of a patient's blood, comprising: a dialyzer; an extracorporeal blood circuit, which runs through the dialyzer via a blood inlet and a blood outlet of the dialyzer, with a sensor unit adapted to determine a blood component in the blood, in particular an oxyhemoglobin content of the blood, which correlates with an oxygen content in the blood, in particular an oxygen partial pressure in the blood, wherein the sensor unit is preferably arranged upstream of the blood inlet; a degassing unit with a throttle device adapted to throttle gas-containing ultrapure water to a degassing pressure in order to provide at least partially degassed ultrapure water at an outlet of the degassing unit, with a pressure detection unit adapted to detect the degassing pressure, wherein the pressure detection unit is arranged in particular downstream of the throttle device, a mixing unit adapted toto mix the at least partially degassed ultrapure water with at least one concentrate to form a fresh dialysis fluid, preferably a dialysis fluid circuit adapted to provide the fresh dialysis fluid at a dialysis fluid inlet, to convey it through the dialyzer and to discharge used dialysis fluid at a dialysis fluid outlet, and a control unit which is signal-connected to the sensor unit, the pressure detection unit and the throttle device.
[0012] According to the disclosure, the throttle device is designed with a continuously adjustable throttle cross-section, which is continuously adjustable depending on a control signal of the control unit, preferably proportional to the control signal.
[0013] Unlike what is known from the prior art, the throttle cross-section of the throttle device is thus continuously adjustable according to the disclosure. In other words, the throttle cross-section can be adjusted / set to a fully open position and a fully closed position, and to corresponding intermediate positions in the control signal. Since the degassing pressure depends on a pressure loss across the throttle device, and the pressure loss in turn – for a given volume flow of the ultrapure water entering the throttle device – is essentially determined by the throttle cross-section, the degassing pressure can be continuously adjusted and influenced between limits according to the disclosure.Since the solubility of gases in a liquid—and thus also of oxygen—is directly dependent on the liquid pressure according to Henry's law (in this case, this pressure is the degassing pressure of the ultrapure water downstream of the throttle device), the oxygen content of the ultrapure water downstream of the throttle device can be adjusted / set by means of the continuously adjustable throttle cross-section according to the disclosure. Since this at least partially degassed ultrapure water is mixed with a concentrate in the mixing unit to form fresh dialysis fluid, the oxygen content of the fresh dialysis fluid can be adjusted / set according to the disclosure.Since the fresh dialysis fluid in the dialyzer is in material exchange with the blood via the dialyzer's semipermeable membrane, and oxygen is permeable to the membrane, this opens up the possibility of influencing the oxygen content in the blood by adjusting / setting the oxygen content of the fresh dialysis fluid. This provides an even more efficient and safer extracorporeal blood treatment therapy using the blood treatment machine designed according to the disclosure.
[0014] A lower limit of the degassing pressure can be achieved with a minimally controlled throttle cross-section, which enables maximum, particularly complete, degassing of the gas-containing ultrapure water. In contrast, an upper limit of the degassing pressure can be achieved with a maximum controlled throttle cross-section, so that no degassing of the gas-containing ultrapure water occurs or only minimal degassing occurs, particularly due to an already occurring flow pressure loss.
[0015] Preferably, the throttle device is designed as an electromagnetically actuated proportional valve or has such a valve and is signal-connected to the control unit.
[0016] In a preferred development, the control unit is adapted to determine the control signal in such a way that, as a result of the adjustment of the throttle cross-section, the oxygen content in the blood is optionally increased, kept constant and / or decreased, so that the oxygen content in the blood is specifically influenced.
[0017] In a further preferred development, the control unit is adapted to determine the control signal such that an oxygen content in the at least partially degassed ultrapure water or the fresh dialysis fluid, in particular an oxygen partial pressure in the at least partially degassed ultrapure water or the fresh dialysis fluid, is adjusted, in particular increased, kept constant and / or decreased, depending on the oxygen content in the blood.
[0018] In a further preferred development, the control unit is adapted to determine the control signal so that a predetermined difference between an oxygen content in the at least partially degassed ultrapure water or the fresh dialysis fluid, in particular an oxygen partial pressure in the at least partially degassed ultrapure water or the fresh dialysis fluid, and the oxygen content in the blood is set, in particular kept constant.
[0019] To determine the control signal, according to a preferred embodiment, a first correlation of the oxygen content in the blood with the blood component is stored in a memory of the blood treatment machine, preferably in a memory of the control unit. Furthermore, the control unit is adapted to retrieve the first correlation and, from this, determine the oxygen content in the blood as a function of the blood component detected by the sensor unit.
[0020] In order to determine the control signal, the control unit is further adapted, according to a preferred development, to determine a target oxygen content in the at least partially degassed ultrapure water or the fresh dialysis fluid from the determined oxygen content in the blood and the predetermined difference, in particular as the sum of the oxygen content in the blood and the predetermined difference.
[0021] According to a preferred development, a second correlation of the oxygen content in the at least partially degassed ultrapure water or the fresh dialysis fluid with the degassing pressure is stored in the memory, and the control unit is adapted to call up the second correlation and to determine therefrom a target degassing pressure as a function of the determined target oxygen content in the at least partially degassed ultrapure water or the fresh dialysis fluid.
[0022] According to a preferred development, a third correlation of the degassing pressure with the control signal is stored in the memory, and the control unit is adapted to call up the third correlation and to determine therefrom the control signal as a function of the determined target degassing pressure and to control the throttle device with the control signal.
[0023] According to a further preferred development, the control unit is adapted to determine a deviation from the predetermined difference permanently, selectively, and / or periodically and to adapt the control signal depending on the deviation.
[0024] According to a possible further development, the extracorporeal blood treatment machine is adapted to carry out an automatic adjustment of the oxygen partial pressures in the blood and in the fresh dialysis fluid in chronic dialysis treatment.
[0025] According to a further possible development, the extracorporeal blood treatment machine is adapted to perform an adjustment of the oxyhemoglobin level in the blood in chronic dialysis treatment.
[0026] According to a further possible further development, the extracorporeal blood treatment machine is adapted to support oxygen supply in acute and chronic dialysis treatment.
[0027] With regard to a computer-implemented control method for an extracorporeal blood treatment machine, in particular a blood treatment machine according to the present disclosure, the object is achieved in that the control method comprises steps: Determining a blood component in the blood, in particular an oxyhemoglobin content in the blood, which correlates with an oxygen content in the blood, in particular an oxygen partial pressure in the blood, via a sensor unit in an extracorporeal blood circuit of the blood treatment machine and providing the determined blood component to a control unit, in particular a control unit of the extracorporeal blood treatment machine; throttling gas-containing ultrapure water to a degassing pressure in order to provide at least partially degassed ultrapure water, via a throttling device, in particular a throttling device of a degassing unit of the extracorporeal blood treatment machine; detecting the degassing pressure via a pressure detection unit, in particular of the degassing unit, and providing the degassing pressure to the control unit;Mixing the at least partially degassed ultrapure water with at least one concentrate to form a fresh dialysis fluid, via a mixing unit, in particular a mixing unit of the extracorporeal blood treatment machine. According to the disclosure, the method comprises the steps of: determining a control signal for controlling the throttle device, which is configured with a throttle cross-section that is adjustable as a function of the control signal, preferably proportional to the control signal, via the control unit; controlling the throttle device with the control signal, via the control unit; and adjusting the throttle cross-section according to the control signal.
[0028] According to a preferred development, the control signal is determined via the control unit in such a way that as a result of the adjustment of the throttle cross-section, the oxygen content in the blood is optionally increased, kept constant and / or decreased.
[0029] The advantages resulting from the disclosed determination of the control signal, the control of the throttle device with the control signal, and the continuous adjustment of the throttle cross-section of the throttle device according to the control signal have already been disclosed above for the blood treatment machine, to which reference is made here. They will therefore not be mentioned again to avoid overloading this document. The computer-implemented control method according to the disclosed method thus provides an even more efficient and safer therapy for extracorporeal blood treatment.
[0030] According to a preferred development, the control signal is determined via the control unit in such a way that an oxygen content in the at least partially degassed ultrapure water or the fresh dialysis fluid, in particular an oxygen partial pressure in the at least partially degassed ultrapure water or the fresh dialysis fluid, is optionally raised, kept constant and / or lowered depending on the oxygen content in the blood.
[0031] According to a preferred development, the control signal is determined via the control unit in such a way that a predetermined difference between an oxygen content in the at least partially degassed ultrapure water or the fresh dialysis fluid, in particular an oxygen partial pressure in the at least partially degassed ultrapure water or the fresh dialysis fluid, and the oxygen content in the blood is set, in particular kept constant.
[0032] According to a particularly preferred development of the computer-implemented control method, a first correlation of the oxygen content in the blood with the blood component, a second correlation of the oxygen content in the at least partially degassed ultrapure water or the fresh dialysis fluid with the degassing pressure, a third correlation of the degassing pressure with the control signal, and the predetermined difference are stored in a memory of the blood treatment machine, preferably in a memory of the control unit. According to the disclosure, the step of determining the control signal can then be performed with the following steps: Calling up the first correlation and determining the oxygen content in the blood as a function of the blood component detected by the sensor unit via the control unit; determining a target oxygen content in the at least partially degassed ultrapure water or the fresh dialysis fluid from the determined oxygen content in the blood and the predetermined difference, in particular as their sum, via the control unit; calling up the second correlation and determining a target degassing pressure as a function of the determined target oxygen content in the at least partially degassed ultrapure water or the fresh dialysis fluid via the control unit; and calling up the third correlation and determining the control signal as a function of the determined target degassing pressure via the control unit.
[0033] With regard to a computer program, the object of the present disclosure is achieved in that this computer program comprises instructions which, when executed by a computer, cause the computer to carry out the method steps of the control method according to the present disclosure. Short description of the characters
[0034] The disclosure is explained in more detail below using preferred embodiments with the aid of figures. They show: Fig. 1 shows a schematic view of an extracorporeal blood treatment machine according to a preferred embodiment; Fig. 2 shows a first correlation of an oxygen content pO 2B in the blood of an extracorporeal blood circuit with a blood component SpO 2B detected by a sensor unit in the blood of the extracorporeal blood circuit, according to the extracorporeal blood treatment machine according to Figure 1; Fig. 3 a time course of the oxygen content pO 2B in the blood of the extracorporeal blood circuit in the case of a constant oxygen content pO 2B in a fresh dialysis fluid, according to the extracorporeal blood treatment machine according to Figure 1 ; Fig. 4 a second correlation of a degassing pressure p E of ultrapure water with the oxygen content pO 2D in the ultrapure water or the fresh dialysis fluid, according to the extracorporeal blood treatment machine according to Figure 1 ; Fig.5 a third correlation of a control signal S for a throttle device with the degassing pressure p E of the ultrapure water, according to the extracorporeal blood treatment machine according to Figure 1 , and Fig. 6 is a flowchart of a computer-implemented control method according to a preferred embodiment.
[0035] The figures are schematic in nature and are intended only to aid understanding of the disclosure. Like elements are designated by like reference numerals. Features of different embodiments may be interchangeable. Detailed description of preferred embodiments
[0036] Figure 1 shows in a schematic view an extracorporeal blood treatment machine 1 in the form of a dialysis machine for extracorporeal blood treatment of blood of a patient P according to a preferred embodiment of the present disclosure.
[0037] In the following, an adjustment or setting of a degassing pressure p E of ultrapure water according to the disclosure is explained, whereby an oxygen content pO 2D in a fresh dialysis fluid of the blood treatment machine 1 can be varied and, as a result, on the basis of a mass exchange at a semipermeable membrane of a dialyzer 2 of the blood treatment machine 1, an oxygen content pO 2D in the blood of an extracorporeal blood circuit 3 of the blood treatment machine 1 can be influenced.
[0038] The extracorporeal blood treatment machine 1 (hereinafter referred to as the blood treatment machine) has, as its central component, a dialyzer 2 with, on the one hand, a dialysis fluid inlet 2.1 and a dialysate outlet 2.2 on the dialysis fluid side, and, on the other hand, a blood inlet 2.3 and a blood outlet 2.4 on the blood side of an extracorporeal blood circuit 3. Within the dialyzer 2, it is divided into a dialysis fluid side and a blood side by means of hollow fibers of a semipermeable membrane 2.5.
[0039] The dialysis fluid inlet 2.1 is fluidically connectable, in particular connected, to a mixing unit 6 via a dialysis fluid inlet 4. This continuously produces fresh dialysis fluid from at least partially degassed ultrapure water, as well as a basic concentrate and an acidic concentrate. The amounts added are controlled by measuring devices. Accordingly, the mixing unit 6 has a first and second source 8, 10 for basic and acidic concentrate, a first and second conveying device 12, 14, and downstream of the conveying devices 12, 14, a first and second measuring device 16, 18, respectively. Figure 1The mixing unit 6 has an inlet 20 at which the at least partially degassed ultrapure water of a degassing unit 5, explained in detail below, is present. Downstream of the second measuring device 18, the mixing unit 6 has a third conveying device 22, via which the mixed, fresh dialysis fluid is conveyed to a balancing device 24. On the output side, the balancing device 24 is fluidly connectable to the dialysis fluid inlet 2.1 of the dialyzer 2 via the dialysis fluid inlet 4, wherein a valve 26 for shutting off the dialysis fluid inlet 2.1 is arranged in the dialysis fluid inlet 4.
[0040] The dialysate outlet 2.2 is fluidically connectable, in particular connected, to a disposal outlet 30 for used dialysis fluid / dialysate via a dialysate outlet 28. Arranged fluidically in series in the dialysate outlet 28 between the dialysate outlet 2.2 and the disposal outlet 30 are: an actuatable valve 34 for shutting off the dialysate outlet 2.2, a detection unit 32a for detecting a component in the dialysate, and a fourth conveying device 36, via which the dialysate is conveyed to the balancing device 24 and to the disposal outlet 30 for dialysate. The balancing device 24 ensures that a desired volume of excess water can be removed from the patient's blood during ultrafiltration. Upstream of the fourth conveying device 36, a pressure detection unit 35 for detecting a dialysate outlet pressure is provided in the dialysate outlet 28.
[0041] Additionally, a bypass flow path 38 is provided, via which the dialysis fluid inlet 4 can be fluidically connected to the dialysate outlet 28. An actuatable valve 40 is arranged in the bypass flow path 38, via which the bypass flow path 38 can be blocked.
[0042] With the aid of the aforementioned fluidic switching means / valves 26, 34, and 40, the dialysis fluid circuit can be switched via the control unit 54 into a main circuit, in which fresh dialysis fluid is provided via the dialysis fluid inlet 4 at the dialysis fluid inlet 2.1 and is conveyed through the dialyzer 2 to the dialysate outlet 2.2. Furthermore, the dialysis fluid circuit can be switched into a bypass circuit by means of the fluidic switching means / valves 26, 34, and 40, in which the dialysis fluid inlet 4 is fluidically separated from the dialysis fluid inlet 2.1 and the dialysate outlet 24 is fluidically separated from the dialysate outlet 2.2, while the dialysis fluid inlet 4 is fluidically connected to the dialysate outlet 24 via the bypass flow path 38.
[0043] On the blood side, the extracorporeal blood circuit 3 is provided, which can withdraw blood from patient P via an arterial tube section 42 and supply it to the dialyzer 2 via the blood inlet 2.3. Arranged in the arterial tube section 42 in the direction of flow are an arterial tube clamp 41, an arterial hematocrit sensor or HCT sensor 44 for detecting an oxyhemoglobin content SpO 2B in the blood, a blood pump 46, and a blood inlet pressure sensor 48. After the blood of patient P has been passed through the blood side of the dialyzer 2 in the extracorporeal blood circuit 3, it is withdrawn at its blood outlet 2.4 and supplied to the shunt S via a venous tube section 50. A blood outlet pressure sensor 52 and a venous tube clamp 43 are arranged in the venous tube section 50.In the dialyzer 2, the blood is led to the dialysis fluid in a countercurrent process and freed from urinary components and excess water and then returned / returned to the patient P in a cleaned state.
[0044] According to Figure 1 the extracorporeal blood treatment machine 1 has a degassing unit 5 for providing at least partially degassed ultrapure water, the inlet 58 of which is connected to a supply connection of a reverse osmosis system (not shown) and at which gas-containing ultrapure water is available.
[0045] Its inlet 58 is connected via an ultrapure water inlet 60 to a degassing tank 62 of the degassing unit 5. An adjustable pressure reducing valve 64, in particular for adjusting an inlet pressure, and a shut-off valve 66, in particular for blocking / opening the ultrapure water inlet 60, are arranged in the ultrapure water inlet 60. The ultrapure water inlet 60 opens into a supply chamber 68 of the degassing tank 62. The supply chamber 68 has two float switches 70, 72, a lower one 70 and an upper one 72, which interact with a float 74 and are signal-connected to the control unit 54.
[0046] A degassing channel 76 is located at the bottom of the supply chamber 68, which fluidically connects the supply chamber 68 to a degassing chamber 80 via a throttle device 78, which is designed as disclosed with a continuously adjustable throttle cross-section and is designed as an electromagnetically actuated proportional valve according to the exemplary embodiment. A pressure detection unit 81 for detecting the degassing pressure p E is arranged in the degassing channel 76 downstream of the throttle device 78. A fixed throttle 82 is provided in fluidically parallel connection to the adjustable throttle device 78, via which a parallel flow path can be formed when the adjustable throttle device 78 is closed.
[0047] The degassing channel 76 opens into the degassing chamber 80 at the bottom. A discharge section 84a of a connecting channel 84 emerges at an apex of the degassing chamber 80 and leads, via a feed pump 86, into a heating chamber 88 of the degassing tank 62. The connecting channel 84 then spirals through the heating chamber 88 and exits at an apex of the heating chamber 88 with a return section 84b. This finally opens into a settling chamber 90 of the degassing tank 62, which is located between the feed chamber 68 and the heating chamber 88. The return section 84b of the connecting channel 84 has a temperature sensor 92 and a shut-off valve 94.
[0048] At the bottom side, a supply channel 96 emerges from the settling chamber 90, which is connected via a check valve 98 to the already mentioned inlet 20 of the mixing unit 6.
[0049] Based on Figure 3The basic idea of the invention – namely to influence the oxygen content in the blood by adjusting the oxygen content in the fresh dialysis fluid – is to be illustrated. To create the graph according to Figure 3 According to the disclosure, a first correlation derived from the graph of the Figure 2 and a second correlation, which is represented by the graph according to Figure 4 represented.
[0050] Figure 2 shows the first correlation of the oxygen content pO 2D in the blood of the extracorporeal blood circuit 3 with the blood component detected by a sensor unit 44 in the blood of the extracorporeal blood circuit 3, that is to say with the oxyhemoglobin content SpO 2B . Figure 4shows the second correlation of the degassing pressure p E of the ultrapure water with the oxygen content pO 2D in the ultrapure water or the fresh dialysis fluid. Both correlations are stored in the memory 56 of the control unit 54 and can be retrieved by the control unit 54.
[0051] According to the Figure 2 In the first correlation shown, the oxygen partial pressure pO 2D in the blood (in mmHg) is plotted on the x-axis, and the oxyhemoglobin content SpO 2B in the blood (in %) is plotted on the y-axis. The first correlation is stored in the memory 56 and can be called up via the control unit 54. Upon calling up the first correlation, the control unit 54 is able to determine the oxygen partial pressure pO 2D in the blood from the oxyhemoglobin content SpO 2B in the blood determined as a percentage by the sensor unit 44.
[0052] The first correlation is based on empirically determined data. The first correlation of the oxyhemoglobin content SpO 2B in the blood with the oxygen partial pressure pO 2D in the blood is preferably stored in memory 56 in the following form: pO 2B SpO 2B = a*e b*SpO 2 B + c*e d*SpO 2B
[0053] According to the Figure 4 In the second correlation shown, the degassing pressure p E is plotted on the X-axis and the oxygen partial pressure pO 2D in the at least partially degassed ultrapure water or the fresh dialysis fluid is plotted on the Y-axis (both in mmHg). The second correlation according to Figure 4is stored in the memory 56 and can be called up via the control unit 54. When the second correlation is called up, the control unit 54 is able to determine the associated oxygen partial pressure pO 2D in the at least partially degassed ultrapure water or the fresh dialysis fluid from the degassing pressure p E detected by the pressure detection unit 81, and conversely, to determine a target degassing pressure p E,soll of the at least partially degassed ultrapure water from a target oxygen partial pressure pO 2D,soll determined by it in the at least partially degassed ultrapure water or the fresh dialysis fluid.
[0054] The second correlation of the oxygen partial pressure pO 2D in the at least partially degassed ultrapure water or the fresh dialysis fluid with the degassing pressure p E is preferably stored in the memory 56 in the following form: pO 2D p E = a*p E + b
[0055] Figure 3combines the temporal profiles of the oxygen partial pressures in the blood pO 2D and in the fresh dialysis fluid pO 2D for an exemplary blood treatment, determined with the aid of the two correlations via the control unit 54. At the beginning (at t = 0) and throughout the entire treatment duration shown (up to t = 200), the oxygen partial pressure pO 2D in the fresh dialysis fluid is approximately 32 mmHg. In the blood, however, the oxygen partial pressure pO 2D is approximately 91 mmHg. Thus, according to Figure 3 a clear gradient of the oxygen content from the blood across the membrane 2.5 of the dialyzer 2 towards the dialysis fluid. The pore size of a dialysis membrane is approximately between 1.8 nm (low flux) and 3.3 nm (high flux). The atomic radius of oxygen, however, is approximately 0.06 nm. In principle, the oxygen dissolved in the dialysis fluid is thus transported across the membrane 2.5 of the dialyzer 2 according to Figure 1highly permeable, so that oxygen transport can be expected depending on the prevailing difference in the oxygen partial pressures pO 2B , pO 2D . In the present exemplary case according to Figure 3 It can actually be observed that the oxygen partial pressure pO 2D in the blood decreases over the treatment period t, from about 91 mmHg to about 86 mmHg.
[0056] Since, as already mentioned, the oxygen partial pressure pO 2D in the fresh dialysis fluid is already at the beginning and throughout the entire duration t considerably below the oxygen partial pressure pO 2D in the blood, it can be stated that the Figure 3 The drop in the oxygen partial pressure pO 2D in the blood shown is due to a transfer of oxygen from the blood into the dialysis fluid.
[0057] Conversely, according to the disclosure, it is possible to influence this transfer by the value of the oxygen partial pressure pO 2D in the fresh dialysis fluid, which is the basic idea of the present disclosure, namely in particular to reduce the transfer or, if necessary, to prevent it or, if necessary, even to reverse it.
[0058] It can therefore be stated that a new functionality - namely, influencing the oxygen content in the blood by adjusting the oxygen content in the fresh dialysis fluid - can be added to extracorporeal blood treatment machines by influencing the oxygen partial pressure pO 2D in the fresh dialysis fluid as disclosed.
[0059] The following is a description of the disclosed degassing of the gas-containing ultrapure water via the degassing unit 62 based on the Figures 1 to 5 and in particular based on the Figure 6, which shows the control method according to the disclosure, computer-implemented in the control unit 54.
[0060] According to Figure 1At the inlet 58 of the degassing unit 62, gas-containing ultrapure water supplied by the reverse osmosis system (not shown) is available. Under normal conditions, this contains considerable quantities of dissolved gases. At an inlet temperature of, for example, 20°C, it contains up to 19 cm³ / l of dissolved gas under normal pressure. The solubility of gas in the ultrapure water is basically described by Henry's law. According to this law, the capacity of the ultrapure water to dissolve gas increases with pressure and decreases with temperature. If a multi-component gas, such as air, is dissolved in a liquid, the individual partial pressures of the components are important for the quantities of gas dissolved in the liquid. Reference is made to the second correlation described above. Approximately one-third of the gas dissolved in the liquid is oxygen, which is easily accessible for measurement.
[0061] According to Figure 1The control unit 54 opens the shut-off valve 66 as long as the upper float switch 72 is not activated. Accordingly, gas-containing ultrapure water flows into the feed chamber 68 and further via the degassing channel 76 to the throttle valve 78. To simplify the description, it is assumed that there is a continuous flow of ultrapure water in the degassing channel 76.
[0062] The computer-implemented control procedure is carried out with one step S0 started or initialized. The start or initialization can, for example, be automated when the blood treatment machine 1 is put into operation or by manual input by an operator via a user interface of the blood treatment machine 1.
[0063] After commissioning, the following steps are continuously carried out: Determine S1of the oxyhaemoglobin content SpO 2B in the arterial blood carried in the extracorporeal blood circuit 3, via the sensor unit 44, and providing S2 of the determined oxyhemoglobin fraction SpO 2B to the control unit 54, as well as the steps of recording S4 the degassing pressure pε, via the pressure detection unit 81 in the degassing channel 76 downstream of the throttle device 78 and providing S5 of the detected degassing pressure p E to the control unit 54.
[0064] By means of the throttle device 78, a throttling step is carried out permanently S3 of the gas-containing ultrapure water to the degassing pressure pε, so that the ultrapure water is fully or partially degassed according to the degassing pressure p E.
[0065] The degassed or partially degassed ultrapure water then flows through the degassing chamber 80, whose surface structure efficiently separates the released gas from the ultrapure water. The degassed or partially degassed ultrapure water exits the degassing chamber 80 and flows back into the settling chamber 90 via the connecting channel 84 and the heating chamber 88, where it can be heated. Here, it is drawn off at the bottom and flows via the check valve to the outlet of the degassing unit 5 and thus to the mixing unit 6.
[0066] In the mixing unit 6 the mixing step then takes place S6 of the degassed or partially degassed ultrapure water with at least one concentrate to the fresh dialysis fluid. The fresh dialysis fluid subsequently enters the dialyzer 2 via the dialysis fluid inlet 4 and the dialysis fluid inlet 2.1.
[0067] With the control procedure according to Figure 6According to the disclosure, the control unit 54 carries out the steps of determining S7 a control signal S for controlling the throttle device 78 and controlling S8 the throttle device 78 with the control signal S, from which the step of adjusting S9 of the throttle cross-section according to the control signal S.
[0068] The Determine Step S7 of the control signal S for controlling the throttle device 78 is carried out in partial steps according to the disclosure S7.1 until S7.4. The basis for the execution of these sub-steps is that the two previously described correlations are stored in the memory 56 according to Figure 2 and 4 , a third correlation of the degassing pressure p E with the control signal S according to Figure 5, as well as a predetermined target oxygen partial pressure difference ΔpO 2, should be stored between the oxygen partial pressure pO 2D in the fresh dialysis fluid and the oxygen partial pressure pO 2D in the blood.
[0069] First, there is a step to call S7.1 the first correlation and determination of the oxygen partial pressure pO 2D in the blood as a function of the oxyhemoglobin content SpO 2B in the blood determined by the sensor unit 44, via the control unit 54 (cf. Figure 2 ). Based on this, a step is carried out to determine S7.2 a target oxygen partial pressure pO 2D,soll in the fresh dialysis fluid as the sum of the determined oxygen partial pressure pO 2D in the blood and the predetermined target oxygen partial pressure difference ΔpO 2,soll , via the control unit 54. This is followed by a step Call S7.3the second correlation and determining a target degassing pressure p E,soll as a function of the determined target oxygen partial pressure pO 2D,soll in the fresh dialysis fluid, via the control unit 54 (cf. Figure 4 ). This is followed by a step to call S7.4 the third correlation and determining the control signal S as a function of the determined target degassing pressure p E,soll , via the control unit 54 (cf. Figure 5 ).
[0070] This means that the step S7 the control signal S is determined in such a way that the gas-containing ultrapure water is throttled to a degassing pressure p E , which leads to a partial degassing, after which the fresh dialysis fluid mixed from the partially degassed ultrapure water has the desired oxygen partial pressure pO 2D,des.
[0071] In addition, the control procedure has a permanent, selective and / or periodic step of determining S10a deviation of the actual oxygen partial pressure difference ΔpO 2,lst from the predetermined oxygen partial pressure difference ΔpO 2,soll and adapting the control signal S to the deviation. List of reference symbols
[0072] 1Extracorporeal blood treatment machine 2Dialyzer 2.1Dialysis fluid inlet 2.2Dialysate outlet 2.3Blood inlet 2.4Blood outlet 2.5Semipermeable membrane 3Extracorporeal blood circuit 4Dialysis fluid inlet 5Degassing unit 6Mixing unit 8First source of acidic concentrate 10Second source of alkaline concentrate 12First conveyor 14Second conveyor 16First measuring device 18Second measuring device 20Ultrapure water inlet 22Third conveyor 24Balancing device 26First valve 28Dialysate outlet 30Disposal outlet 32Detection unit 34Second valve 38Bypass flow path 40Third valve 41Arterial tube clamp 42Arterial tube section 43Venous tube clamp 44Blood component sensor 46Blood pump 48Blood inlet pressure sensor 50Venous tube section 52Blood outlet pressure sensor 54Control unit 56Storage unit 58Degassing unit inlet 60Ultrapure water inlet 62Degassing tank 64Pressure reducing valve 66Shut-off valve 68Pre-flow chamber 70,72Float switch 74Float 76Degassing channel 78Adjustable throttle device 80Degassing chamber 81Pressure detection unit 82Fixed throttle 84Connecting channel 86Feed pump 88Heating chamber 90Settling chamber 92Temperature sensor 94Check valve 96Supply channel 98Check valve , S0Start control procedure S1Step Determine blood component S2Step Provide blood component S3Step Throttle gas-containing ultrapure water S4Step Determine degassing pressure S5Step Provide degassing pressure S6Step Mix fresh dialysis fluid S7Step Determine control signal S7.1Step Determine blood oxygen content S7.2Step Determine target oxygen content of dialysis fluid S7.3Step Determine target degassing pressure S7.4Step Determine control signal from target degassing pressure S8Step Control throttle device S9Step Adjust throttle cross-section S10Step Adjust target partial pressure difference oxygen content PPatient SShunt SpO 2B Blood component pO 2D Oxygen content of blood pO 2D Oxygen content of ultrapure water / fresh dialysis fluid pO 2D,target Target oxygen content of ultrapure water / fresh dialysis fluid ΔpO 2,target Predetermined difference p E Degassing pressure p E,target Target degassing pressure SControl signal
Claims
1. Extracorporeal blood treatment machine (1), in particular a dialysis machine, for extracorporeal blood treatment of blood of a patient (P), comprising: - a dialyzer (2), - an extracorporeal blood circuit (3), which runs through the dialyzer (2) via a blood inlet (2.3) and a blood outlet (2.4) of the dialyzer (2), with a sensor unit (44) which is adapted to measure a blood component (SpO 2B ) in the blood, in particular an oxyhaemoglobin content of the blood that corresponds to an oxygen content (pO 2B ) in the blood, in particular an oxygen partial pressure in the blood, wherein the sensor unit (44) is preferably arranged upstream of the blood inlet (2.3), - a degassing unit (5) with a throttle device (78) which is adapted to reduce gas-containing ultrapure water to a degassing pressure (p E) in order to provide at least partially degassed ultrapure water at an outlet (96) of the degassing unit (5), with a pressure detection unit (81) which is adapted to detect the degassing pressure (p E ), wherein the pressure detection unit (81) is arranged in particular downstream of the throttle device (78), - a mixing unit (6) which is adapted to mix the at least partially degassed ultrapure water with at least one concentrate to form a fresh dialysis fluid, and - a control unit (54) which is signal-connected to the sensor unit (44), the pressure detection unit (81) and the throttle device (78), characterized in that the throttle device (78) is designed with a continuously adjustable throttle cross-section which is continuously adjustable as a function of a control signal (S) of the control unit (54), preferably proportional to the control signal (S).
2. Extracorporeal blood treatment machine (1) according to claim 1, characterized in that the control unit (54) is adapted to determine the control signal (S) in order to determine the oxygen content (pO 2B ) in the blood to raise, maintain constant and / or lower.
3. Extracorporeal blood treatment machine (1) according to claim 1 or 2, characterized in that the control unit (54) is adapted to determine the control signal (S) in order to determine an oxygen content (pO 2D ) in the at least partially degassed ultrapure water or the fresh dialysis fluid, in particular an oxygen partial pressure in the at least partially degassed ultrapure water or the fresh dialysis fluid, depending on the oxygen content (pO 2B ) in the blood, in particular to raise, maintain constant and / or lower.
4. Extracorporeal blood treatment machine (1) according to one of the preceding claims, characterized in thatthe control unit (54) is adapted to determine the control signal (S) in order to obtain a predetermined difference (ΔpO 2,soll ) between an oxygen content (pO 2D ) in the at least partially degassed ultrapure water or the fresh dialysis fluid, in particular an oxygen partial pressure in the at least partially degassed ultrapure water or the fresh dialysis fluid, and the oxygen content (pO 2B ) in the blood, especially to keep it constant.
5. Extracorporeal blood treatment machine (1) according to one of the preceding claims, characterized in that in a memory (56) of the blood treatment machine (1), preferably in a memory (56) of the control unit (54), a first correlation of the oxygen content (pO 2B ) in the blood with the blood component (SpO 2B ) is stored, and that the control unit (54) is adapted to call up the first correlation and to determine the oxygen content (pO 2B) in the blood depending on the blood component (SpO 2B ) to determine.
6. Extracorporeal blood treatment machine (1) according to claim 4 and 5, characterized in that the control unit (54) is adapted to provide a target oxygen content (pO 2D,soll ) in the at least partially degassed ultrapure water or the fresh dialysis fluid from the determined oxygen content (pO 2B ) in the blood and the predetermined difference (ΔpO 2,soll ), in particular as their sum.
7. Extracorporeal blood treatment machine (1) according to claim 6, characterized in that in the memory (56) a second correlation of the oxygen content (pO 2D ) in the at least partially degassed ultrapure water or the fresh dialysis fluid with the degassing pressure (p E ) is stored, and that the control unit (54) is adapted to call up the second correlation and to determine a desired degassing pressure (p E,soll) depending on the determined target oxygen content (pO 2D.soll ) in the at least partially degassed ultrapure water or the fresh dialysis fluid.
8. Extracorporeal blood treatment machine (1) according to claim 7, characterized in that in the accumulator (56) a third correlation of the degassing pressure (p E ) with the control signal (S), and that the control unit (54) is adapted to call up the third correlation and to adjust the control signal (S) as a function of the determined desired degassing pressure (p E,soll ) and to control the throttle device (78) with the control signal (S).
9. Extracorporeal blood treatment machine (1) at least according to claim 4, characterized in that the control unit (54) is adapted to detect a deviation from the predetermined difference (ΔpO 2,soll ) permanently, selectively, and / or periodically and to adapt the control signal (S) depending on the deviation.
10. Computer-implemented control method for an extracorporeal blood treatment machine (1) with a dialyzer (2), in particular a blood treatment machine (1) according to one of the preceding claims, comprising the steps of: - determining (S1) a blood component (SpO 2B ) in the blood, in particular an oxyhemoglobin fraction, which is associated with an oxygen content (pO 2B ) in the blood, in particular an oxygen partial pressure in the blood, via a sensor unit (44) in an extracorporeal blood circuit (3) of the blood treatment machine (1), - providing (S2) the determined blood component (SpO 2B ) to a control unit (54); - throttling (S3) of gas-containing ultrapure water to a degassing pressure (p E ) to provide at least partially degassed ultrapure water, via a throttle device (78), - detecting (S4) the degassing pressure (p E ), via a pressure detection unit (81), - providing (S5) the degassing pressure (pE ) to the control unit (54); - mixing (S6) the at least partially degassed ultrapure water with at least one concentrate to form a fresh dialysis fluid, via a mixing unit (6), characterized by Steps - determining (S7) a control signal (S) for controlling the throttle device (78), which is designed with a throttle cross-section that is adjustable as a function of the control signal (S), preferably proportional to the control signal (S), via the control unit (54); - controlling (S8) the throttle device (78) with the control signal (S), via the control unit (54); and - adjusting (S9) the throttle cross-section according to the control signal (S).
11. Computer-implemented control method according to claim 10, characterized in that the control signal (S) is determined via the control unit (54) in such a way that the oxygen content (pO 2B ) in which blood is optionally raised, kept constant and / or lowered.
12. Computer-implemented control method according to claim 10 or 11, characterized in that the control signal (S) is determined via the control unit (54) in such a way that an oxygen content (pO 2D ) in the at least partially degassed ultrapure water or the fresh dialysis fluid, in particular an oxygen partial pressure in the at least partially degassed ultrapure water or the fresh dialysis fluid, depending on the oxygen content (pO 2B ) in which blood is optionally raised, kept constant and / or lowered.
13. Computer-implemented control method according to one of claims 10 to 12, characterized in that the control signal (S) is determined via the control unit (54) in such a way that a predetermined difference (ΔpO 2,soll ) between an oxygen content (pO 2D) in the at least partially degassed ultrapure water or the fresh dialysis fluid, in particular an oxygen partial pressure in the at least partially degassed ultrapure water or the fresh dialysis fluid, and the oxygen content (pO 2B ) in the blood is adjusted, in particular kept constant.
14. Computer-implemented control method according to claim 13, wherein in a memory (56) of the blood treatment machine (1), preferably in a memory (56) of the control unit (54), a first correlation of the oxygen content (pO 2B ) in the blood with the blood component (SpO 2B ), a second correlation of the oxygen content (pO 2D ) in the at least partially degassed ultrapure water or the fresh dialysis fluid with the degassing pressure (p E ), a third correlation of the degassing pressure (p E ) with the control signal (S), as well as the predetermined difference (ΔpO 2,soll ) are stored, characterized bySteps for determining (S7) the control signal (S): - Calling (S7.1) the first correlation and determining the oxygen content (pO 2B ) in the blood depending on the blood component (SpO 2B ), via the control unit (54); - determining (S7.2) a target oxygen content (pO 2D,soll ) in the at least partially degassed ultrapure water or the fresh dialysis fluid from the determined oxygen content (pO 2B ) in the blood and the predetermined difference (ΔpO 2,soll ), in particular as their sum, via the control unit (54); - calling (S7.3) the second correlation and determining a target degassing pressure (p E,soll ) depending on the determined target oxygen content (pO 2D,soll) in the at least partially degassed ultrapure water or the fresh dialysis fluid, via the control unit (54); and - calling (S7.4) the third correlation and determining the control signal (S) as a function of the determined target degassing pressure (p E,soll ), via the control unit (54).
15. A computer program comprising instructions which, when executed by a computer, cause the computer to carry out the method steps of the control method according to one of claims 10 to 14.
Citation Information
Patent Citations
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